BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821309 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00361
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    February 24, 2012
    Manufacturer
    IMEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS DURING INITIAL TESTING. THE ERROR LOG REVEALED THAT THE UNIT EXHIBITED TEN E3 ERRORS ON THE LAST DAY OF USE. TESTING OF THE SPLIT FOIL PAD SHOWED THAT THE SYSTEM COULD DELIVER ENERGY TO A SPLIT FOIL PAD WITHOUT TRIGGERING FALSE E3 ERRORS. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GENERATOR WAS NOT WORKING PROPERLY, IT WAS "THROWING AND E8 (OVERCURRENT ERROR) CODE EVERY TIME IT WAS USED". THIS OCCURRED DURING CASES; PRESSING THE FOOTSWITCH/HANDPIECE WOULD CLEAR THE ERROR. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI IMEDTRONIC ADVANCED ENERGY LLC PULSAR II

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE